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Medikamente freisetzende Koronarstents und mit Medikamenten beschichtete Ballonkatheter

Positionspapier der DGK 2011

Drug-eluting coronary stents and drug-coated balloon catheters

2011 Position Paper of the German Cardiac Society

  • Positionspapier
  • Published:
Der Kardiologe Aims and scope

Zusammenfassung

Das Positionspapier der DGK zu Medikamente freisetzende Stents (DES) und mit Medikamenten beschichtete Ballonkatheter (DCB) fokussiert auf in Deutschland zugelassene und verfügbare Produkte, die in klinischen Studien untersucht wurden. Es sind für alle Produkte randomisierte, kontrollierte klinische Studien mit primärem angiographischem Endpunkt zum Nachweis der antirestenotischen Wirksamkeit und nachfolgend klinische Endpunktstudien zu fordern. Der Einsatz von DES führt im Vergleich zu unbeschichteten Stents (BMS) zu einer Reduktion erneuter Revaskularisationen, während sich die klinischen Endpunkte wie Tod oder Myokardinfarkt nicht ändern. DES sollten bevorzugt bei erhöhtem Risiko einer Instentstenose eingesetzt werden. Bei erhöhtem Risiko für eine Stentthrombose oder zu erwartenden Problemen bei einer verlängerten dualen Thrombozytenaggregationshemmung (DTAH) ist der Einsatz von BMS zu bevorzugen. Die Dauer einer DTAH beträgt 1 Monat nach BMS-Implantation, 1 Monat nach Therapie der BMS-ISR mit DCB, 6 bis 12 Monate nach DES-Implantation bei allen Patienten sowie grundsätzlich 12 Monate nach akutem Koronarsyndrom (ACS) unabhängig von der Art der Intervention.

Abstract

The Position Paper of the German Cardiac Society on drug-eluting stents (DES) and drug-coated balloon catheters (DCB) focuses on products which are approved for use and are available in Germany after successful investigation in clinical trials. Randomized, controlled clinical trials with the primary angiographic endpoint of providing evidence for antirestenotic efficacy should be required for all products as well as subsequent clinical endpoint trials. The use of DES in comparison to bare metal stents (BMS) leads to reduction of repeat revascularizations, while the clinical endpoints such as death or myocardial infarction remain unchanged. DES should be preferred in cases of increased risk for in-stent stenosis (ISR). In cases of elevated risk for stent thrombosis or expected problems of prolonged dual antiplatelet therapy, preference should be given to the use of BMS. The duration of dual antiplatelet therapy should be 1 month after BMS implantation, 1 month after treatment of BMS ISR with DCB, and 6–12 months after DES implantation in all patients and as a matter of principle 12 months after acute coronary syndrome (ACS) irrespective of the type of intervention.

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Abbreviations

ACS:

„Acute coronary syndrome“, akutes Koronarsyndrom

BMS:

„Bare metal stent“, unbeschichteter Metallstent

CABG:

Koronar-arterielle Bypassoperation

CTO:

„Chronic total occlusion“, chronischer Koronararterienverschluss

DTAH:

Kombinierte („duale“) Thrombozytenaggregationshemmung

DCB:

„Drug coated balloon“, medikamentenbeschichteter Ballon

DES:

„Drug eluting stent“, Medikamente freisetzender Stent

ISR:

„In-stent restenosis“, Instentstenose

KHK:

Koronare Herzkrankheit

LLL:

„Late lumen loss“, angiographischer Lumenverlust

MACE:

„Major adverse cardiac events“, schwere kardiale Ereignisse (meist Tod, Myokardinfarkt, TLR)

NSTEMI:

„Non-ST-elevation myocardial infarction“, Herzinfarkt ohne ST-Hebung

PCI:

„Percutaneous coronary intervention“, perkutane Koronarintervention

POBA:

„Poor old balloon angioplasty“, alleinige Ballonaufdehnung

PTCA:

Perkutane transluminale koronare Angioplastie

RCT:

„Randomized clinial trials“, randomisierte klinische Studien

STEMI:

„ST-elevation myocardial infarction“, Herzinfarkt mit ST-Hebung

TAH:

Thrombozytenaggregationshemmung

TLF:

„Target lesion failure“, Therapieversagen an der Zielläsion

TLR:

„Target lesion revascularization“, erneute Revaskularisation der Zielläsion

TVF:

„Target vessel failure“, Therapieversagen im Zielgefäß

TVR:

„Target vessel revascularization“, erneute Revaskularisation des Zielgefäßes

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Interessenkonflikt

Der korrespondierende Autor weist auf folgende Beziehungen hin:

Bruno Scheller: Beratertätigkeit: Abbott, B. Braun. Forschungsunterstützung: B. Braun, Cordis. Vortragshonorare: B. Braun, Medtronic, Abbott, Astra Zeneca. Andere: genannt als Miterfinder auf einer Patentanmeldung der Charite, Berlin zu unterschiedlichen Verfahren der Restenosehemmung einschließlich beschichteter Ballonkatheter; Teilhaber InnoRa GmbH.

Benny Levenson: Beratertätigkeit: nein. Forschungsunterstützung: nein. Vortragshonorare: Astra Zeneca. Andere: nein.

Michael Joner: Beratertätigkeit: Biotronik, Abbott, Medtronic. Forschungsunterstützung: Biotronik, Abbott, Medtronic. Vortragshonorare: Biotronik, Abbott, Medtronic. Andere: nein.

Ralf Zahn: Beratertätigkeit: nein. Forschungsunterstützung: nein. Vortragshonorare: Cordis, Boston Scientific, Lilly, Bristol-Myers Squibb. Andere: nein.

Volker Klauss: Beratertätigkeit: nein. Forschungsunterstützung: nein. Vortragshonorare: Medtronic, Abbott, Biosensor, Cordis, Terumo. Andere: nein.

Christoph Naber: Beratertätigkeit: Biosensors, Biotronik. Forschungsunterstützung: Abbott, Biosensors, Biotronik, Icon Interventional, Medtronic, Stentys. Vortragshonorare: Abbott, Biosensors, Biotronik, Boston Scientific, Cordis, Eurocor, Lilly, Medtronic, Stentys, Terumo. Andere: nein.

Volker Schächinger: Beratertätigkeit: Abbott, Cordis. Forschungsunterstützung: Terumo. Vortragshonorare: Berlin-Chemie, Boehringer Ingelheim, Boston Scientific, Lilly. Andere: nein.

Albrecht Elsässer: Beratertätigkeit: Daichi Sankyo, Lilly, Medicines Company, Terumo, Translumina. Forschungsunterstützung: keine. Vortragshonorare: Daichi Sankyo, Lilly, Medtronic, MSD, Novartis, Terumo, Translumina. Andere: nein.

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Authors and Affiliations

  1. Klinische und Experimentelle Interventionelle Kardiologie, Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Kirrbergerstr., 66424, Homburg/Saar, Deutschland

    B. Scheller

  2. Kardiologische Gemeinschaftspraxis und Herzkatheterlabor Berlin-Charlottenburg, Berlin, Deutschland

    B. Levenson

  3. Deutsches Herzzentrum München und 1. Medizinische Klinik, Klinikums rechts der Isar, Technische Universität München, München, Deutschland

    M. Joner

  4. Kardiologie, Herzzentrum Ludwigshafen, Ludwigshafen, Deutschland

    R. Zahn

  5. Kardiologie-Innenstadt, München, Deutschland

    V. Klauss

  6. Klinik für Kardiologie und Angiologie, Elisabeth-Krankenhaus Essen, Essen, Deutschland

    C. Naber

  7. Medizinische Klinik I/Kardiologie, Klinikum Fulda, Fulda, Deutschland

    V. Schächinger

  8. Klinik für Kardiologie, Klinikum Oldenburg gGmbH, Integriertes Herzzentrum, Oldenburg, Deutschland

    A. Elsässer

Authors
  1. B. Scheller
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  2. B. Levenson
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  3. M. Joner
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  4. R. Zahn
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  5. V. Klauss
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  6. C. Naber
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  7. V. Schächinger
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  8. A. Elsässer
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Arbeitsgruppe Interventionelle Kardiologie (AGIK) der Deutschen Gesellschaft für Kardiologie (DGK)

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Correspondence to B. Scheller.

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Scheller, B., Levenson, B., Joner, M. et al. Medikamente freisetzende Koronarstents und mit Medikamenten beschichtete Ballonkatheter. Kardiologe 5, 411–435 (2011). https://doi.org/10.1007/s12181-011-0375-6

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  • DOI: https://doi.org/10.1007/s12181-011-0375-6

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